Tolerance and Efficacy of Wondersun Infant Formula in Formula-fed Chinese Term Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01157390
Recruitment Status : Completed
First Posted : July 7, 2010
Last Update Posted : June 8, 2017
Information provided by (Responsible Party):
Yu-ming Chen, Sun Yat-sen University

Brief Summary:

Objective: To demonstrate the well-being of Chinese term infants fed with Wondersun formula with high proportion of palmitic acid in the sn-2 position.

Design & setting: A single-center, open label study. A breast fed group will serve as reference. The study will be conducted in Guangzhou from 2010.1~2010.12.

Participants: 0-14 d whole formula-fed infants and whole breast-fed infants, 30 infants in each group. They are required to be healthy, term-infant, and with normal birth weight, and have no medications known to affect their growth and development.

Intervention: The formula-fed infants will be fed Wondersun formula with high proportion of palmitic acid in the sn-2 position; and breast-fed groups will be fed using breast milk for at least 3 month.

Outcome measures: Tolerance and efficacy will be assessed by body measurement, stool characteristics questionnaire, general health examination, and behavior and habit questionnaire at baseline (0-14d), 6 weeks and 12 weeks. Safety will also be evaluated.

Statistical analysis: t-test, rank test and chi-square test will be used to examine the significance of change from baseline to follow-up visit between the formula-fed and breast-fed groups for effectiveness measures

Condition or disease Intervention/treatment Phase
Infant Nutrition Other: Infant formula Other: Breast feeding Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Tolerance and Efficacy of Wondersun Infant Formula in Formula-fed Chinese Term Infants: an Open Label, Controlled Trial
Study Start Date : February 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Infant formula
The infants will be fed with Wondersun infant formula with high proportion of palmitic acid at the sn-2 position
Other: Infant formula
Name: Infant formula with high proportion of palmitic acid in the sn-2 position Dosage & frequency: Fed as need Duration: at least 3 months
Other Name: Wondersun Brand An Li Cong Infant Formula

Active Comparator: Breast feeding
Complete breast feed within the first 3 month
Other: Breast feeding
Breast feeding
Other Name: Not relevant

Primary Outcome Measures :
  1. Anthropometric parameters [ Time Frame: 12 weeks ]
    body length, body weight, and head circumferences

Secondary Outcome Measures :
  1. Efficacy and safety [ Time Frame: 6 weeks ]
    Stool characteristics General health and wellbeing Behavior and habits Adverse events Concomitant medications Covariates or potential confounders

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Parental/legal guardian written informed consent.
  • The mother had unequivocally decided not to breast-feed (for formula fed infants) or to breastfeed (for human milk fed infants).
  • Term infant of Chinese origin born at 37-42 gestation weeks as determined by menstrual history and corroborated by prenatal Unltra-Sound (US) and/or physical examination.
  • Birth weight appropriate for gestational age (AGA), 2500-4000g (between 10th~ 90th percentile of body weight at same gestation age).
  • The infant is apparent healthy at birth and entry to study.
  • Apgar after 5 minutes >7.
  • Enrolled within their first 14 days after birth.
  • The infant is a product of normal pregnancy and delivery including C-section.
  • Patental ability to attend visits, interviews and willing to fill questionnaires.

Exclusion Criteria:

  • Mother health condition: (psychological of physical) or socioeconomic problems that may interfere with the mother's ability to take care of her infant.
  • The infant suffers from a major congenital abnormality or chromosomal disorder with a clinical significance that can be detected at birth.
  • The infant suffers/ed from a disease requiring mechanical ventilation or medication treatment at the first week after birth.
  • The infant suffers from any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula).
  • The infant is a carry of HBV (HBsAb positive).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01157390

China, Guangdong
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
Sponsors and Collaborators
Sun Yat-sen University
Principal Investigator: Yuming Chen, PhD Sun Yat-sen University

Publications of Results:
Zhong W, Tang XY, Hou HY, Liora L, Yael L, Yonatan M, Fabiana BY, Wei M, Su YX, Chen YM.Tolerance and Efficacy of Infant Formula with High Sn-2 Palmitate in Formula- Fed Chinese Term Infants: an Open Label, Controlled Trial. J Nutr Health Food Eng 2016 Mar 15; 4(2): 00122. DOI: 10.15406/jnhfe.2016.04.00122

Responsible Party: Yu-ming Chen, Professor, Sun Yat-sen University Identifier: NCT01157390     History of Changes
Other Study ID Numbers: INF-004
First Posted: July 7, 2010    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: June 2017

Keywords provided by Yu-ming Chen, Sun Yat-sen University:
sn-2 palmitic acid
infant formula

Additional relevant MeSH terms:
Palmitic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action